Biomarkers for Traumatic Brain Injury: Data Standards and Statistical  Considerations.

Biomarkers; Brain Injuries, Traumatic/diagnosis; Common Data Elements; Data Interpretation, Statistical; Humans; Information Dissemination; Reference Standards; biomarkers; data sharing; traumatic brain injury

Abstract :

[en] Recent biomarker innovations hold potential for transforming diagnosis, prognostic modeling, and precision therapeutic targeting of traumatic brain injury (TBI). However, many biomarkers, including brain imaging, genomics, and proteomics, involve vast quantities of high-throughput and high-content data. Management, curation, analysis, and evidence synthesis of these data are not trivial tasks. In this review, we discuss data management concepts and statistical and data sharing strategies when dealing with biomarker data in the context of TBI research. We propose that application of biomarkers involves three distinct steps-discovery, evaluation, and evidence synthesis. First, complex/big data has to be reduced to useful data elements at the stage of biomarker discovery. Second, inferential statistical approaches must be applied to these biomarker data elements for assessment of biomarker clinical utility and validity. Last, synthesis of relevant research is required to support practice guidelines and enable health decisions informed by the highest quality, up-to-date evidence available. We focus our discussion around recent experiences from the International Traumatic Brain Injury Research (InTBIR) initiative, with a specific focus on four major clinical projects (Transforming Research and Clinical Knowledge in TBI, Collaborative European NeuroTrauma Effectiveness Research in TBI, Collaborative Research on Acute Traumatic Brain Injury in Intensive Care Medicine in Europe, and Approaches and Decisions in Acute Pediatric TBI Trial), which are currently enrolling subjects in North America and Europe. We discuss common data elements, data collection efforts, data-sharing opportunities, and challenges, as well as examine the statistical techniques required to realize successful adoption and use of biomarkers in the clinic as a foundation for precision medicine in TBI.

Disciplines :

Human health sciences: Multidisciplinary, general & others

Author, co-author :

Huie, J Russell; Brain and Spinal Injury Center, Department of Neurological Surgery, University of

Mondello, Stefania; Department of Biomedical and Dental Sciences and Morphofunctional Imaging,

Lindsell, Christopher J; Department of Biostatistics, Vanderbilt University Medical Center, Nashville,

Antiga, Luca; Orobix Srl, Bergamo, Italy.

Yuh, Esther L; Brain and Spinal Injury Center, Department of Neurological Surgery, University of

Zanier, Elisa R; Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.

Masson, Serge; Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.

Rosario, Bedda L; Department of Epidemiology, University of Pittsburgh Graduate School of Public

Ferguson, Adam R; Brain and Spinal Injury Center, Department of Neurological Surgery, University of ; San Francisco Veterans Affairs Medical Center (SFVAMC), San Francisco, California,

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI)

Other collaborator :

Adeoye, Opeolu

Badjatia, Neeraj

Boase, Kim

Bodien, Yelena

Bullock, M Ross

Chesnut, Randall

Corrigan, John D

Crawford, Karen

Diaz-Arrastia, Ramon

Dikmen, Sureyya

More authors (371 more)

Language :

English

Title :

Biomarkers for Traumatic Brain Injury: Data Standards and Statistical Considerations.

Publication date :

15 September 2021

Journal title :

Journal of Neurotrauma

ISSN :

0897-7151

eISSN :

1557-9042

Publisher :

Mary Ann Liebert, Us ny

Volume :

Issue :

Pages :

2514-2529

Peer reviewed :

Peer Reviewed verified by ORBi

Funding number :

UG3 NS106899/NS/NINDS NIH HHS/United States; I01 RX002787/RX/RRD VA/United States; R01 NS088475/NS/NINDS NIH HHS/United States; UH3 NS106899/NS/NINDS NIH HHS/United States; I01 RX002245/RX/RRD VA/United States

Available on ORBi :

since 27 March 2022

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